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3SHAPE Medical A/S

Matched from indexed company URL: 3SHAPE MEDICAL A

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
301070094830107009483SHAPE Medical A/S1N2020-04-25Holmens Kanal 7 Copenhagen K Region Hovedstaden DK 1060

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05902729750448Implant Studio - Dental treatment application software+4570272620support@3shape.com
05902729750455CT Preparation - Dental treatment application software+4570272620support@3shape.com
05902729753265Implant Studio - Dental treatment application software+4570272620support@3shape.com
059027683653063Shape Implant Studio - IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used as pre-operative planning soft-ware to plan the placement of one or more implants based on an imported CBCT scan and optionally aligned with a loaded 3D surface scan. The implants are provided by a secured implant library. In addition Virtual Crowns can be used for optimized implant positioning under the esthetical aspect. Further a surgical guide for a guided surgery can be designed and exported for 3rd party fabrication based on the approved implant position. The use of the software requires to have the necessary expertise in implant dentistry.The IMPLANT STUDIO IPGS system must be operated by trained dental practitioners and dental technicians who are skilled in implant dentistry.The IMPLANT STUDIO IPGS software is to be used in general dentist clinics and dental laboratories.+4570272620support@3shape.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1677532001228329K141570IMPLANT STUDIOLLZ2014-10-31

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LLZ12014-10-31

PMN#

GUDID#

3Shape Implant Studio - IMPLANT STUDIO IPGS (Implant Planning and Surgical Guide) is intended to be used as pre-operative planning soft-ware to plan the placement of one or more implants based on an imported CBCT scan and optionally aligned with a loaded 3D surface scan. The implants are provided by a secured implant library. In addition Virtual Crowns can be used for optimized implant positioning under the esthetical aspect. Further a surgical guide for a guided surgery can be designed and exported for 3rd party fabrication based on the approved implant position. The use of the software requires to have the necessary expertise in implant dentistry.The IMPLANT STUDIO IPGS system must be operated by trained dental practitioners and dental technicians who are skilled in implant dentistry.The IMPLANT STUDIO IPGS software is to be used in general dentist clinics and dental laboratories.

3shape Medical A/S

2016-08-25